Zyga Receives 510(k) Clearance for SImmetry® Sacroiliac Joint Fusion System Updates
New Procedural Option Allows SI Joint Fusion Through Single Incision
MINNETONKA, Minn. – August 13, 2015 – Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SImmetry System using either a two-incision or a single-incision technique.
“In the operating room, surgeons need as many options as possible to effectively treat each individual,” said David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine. “This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.”
The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in U.S. adults[i]. It has been reported that approximately 20 percent of all chronic LBP derives from the sacroiliac joint[ii]. In January 2015, the Centers for Medicare and Medicaid Services (CMS) assigned a Category 1 CPT code to minimally invasive SI joint fusion, improving patient access to the procedure.
About Zyga Technology, Inc.
Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, a non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. For more information, visit zyga.com.
[i] Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
[ii] Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116